vaccine therapy plus radiation therapy in treating patients with non-small cell lung cancer that has been completely removed in surgery

Conditions: Lung Cancer

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. radiation therapy uses high-energy x-rays to damage tumor cells. combining these two treatments may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage ii or stage iiia non-small cell lung cancer that has been completely removed in surgery.

objectives: * determine the humoral and t-cell response to adjuvant monoclonal antibody 11d10 anti-idiotype vaccine and monoclonal antibody 3h1 anti-idiotype vaccine with radiotherapy in patients with completely resected stage ii or iiia non-small cell lung cancer. * determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. * determine the progression-free and overall survival of patients treated with this regimen. outline: this is a multicenter study. patients receive monoclonal antibody 11d10 anti-idiotype vaccine and monoclonal antibody 3h1 anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning 2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2 years regardless of disease progression. beginning no more than 1 week after the third postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks. patients with extracapsular nodal metastases or t3 lesions also undergo 6 additional radiotherapy boosts. patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 54 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed stage ii or iiia non-small cell lung cancer * t1-3, n1-2, m0 * no stage iiib (e.g., contralateral n3), stage iv (m1), or t3, n0, m0 disease * n1 disease eligible only if hilar lymph node involvement present * no bronchoalveolar carcinoma with lobar or multilobar involvement * no small cell lung carcinoma, including mixed histology * no more than 7 weeks since prior surgery (lobectomy, sleeve resection, bilobectomy, or pneumonectomy) * negative surgical margins * no incompletely resected gross disease or * no microscopically positive bronchial or vascular margins * no known cns metastasis patient characteristics: age: * 18 and over performance status: * zubrod 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 2,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * not specified renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance greater than 60 ml/min cardiovascular: * no superior vena cava syndrome pulmonary: * fev_1 at least 1.0 l gastrointestinal: * no prior celiac disease, familial polyposis, turcot's syndrome, gardner's syndrome, peutz-jegher's syndrome, or hereditary non-polyposis colon cancer * no prior colitis, inflammatory bowel disease, or pancreatitis within the past 10 years other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no known sensitivity to rodent proteins * no prior hypersensitivity or contraindication to study treatments (e.g., monoclonal antibody 11d10 anti-idiotype vaccine, monoclonal antibody 3h1 anti-idiotype vaccine, aluminum hydroxide, or murine proteins) or any excipients * no prior clinically significant hypersensitivity reactions (e.g., angioedema, anaphylaxis, or serious dermatological manifestations) or asthmatic attacks requiring hospitalization * no prior immune or immunodeficiency disorders (e.g., hiv, sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders) * no prior seizure disorder requiring continuous medication * no active infection * no other prior or concurrent malignancy within the past 3 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer * no medical contraindication to surgery, radiotherapy, or immunotherapy * no prior drug or alcohol abuse (excluding nicotine) within the past 12 months * no prior psychiatric or addictive disorder that would preclude study compliance prior concurrent therapy: biologic therapy: * no prior murine antibodies (e.g., oncoscint scan) * no prior monoclonal antibody 11d10 anti-idiotype vaccine, monoclonal antibody 3h1 anti-idiotype vaccine, or other investigational carcinoembryonic antigen-derived therapy * at least 3 years since other prior immunotherapy * at least 30 days since prior immunization (e.g., influenza) * no immunomodulatory therapy (e.g., gold, auranofin, hydroxychloroquine, sulfasalazine, penicillamine, levamisole, dapsone, azathioprine, intravenous immunoglobulin, leukotriene antagonists, cromoglycate, ketotifen, nedocromil, psoralin-ultraviolet-light, or plasmapheresis) within 30 prior to the first dose of study drug or 5 half-lives of the action of the agent, whichever is longer chemotherapy: * at least 3 years since prior chemotherapy except topical therapy * no concurrent methotrexate or cyclophosphamide endocrine therapy: * at least 45 days since prior corticosteroids * no concurrent systemic corticosteroids radiotherapy: * no prior thoracic radiotherapy surgery: * see disease characteristics other: * at least 45 days since prior immunosuppressants * no investigational agents within 30 prior to the first dose of study drug or 5 half-lives of the action of the agent, whichever is longer * no concurrent amifostine * no concurrent cyclosporine * no other concurrent immunosuppressants * no concurrent chronic systemic antihistamines

Keywords: stage ii non-small cell lung cancer stage iiia non-small cell lung cancer